On Monday, September 23, 2019, United States Pharamacopeia (USP) announced it is postponing enforcement of USP Chapters <795>, <797> and <825> originally scheduled for December 1, 2019 after receiving appeals on certain provisions. Additionally, it announced USP Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019, however is considered informational and not compendially applicable during the postponement and pending resolutions of appeals of <795> and <797>.
Sterile compounding expert, Eric S. Kastango discusses the announcement from USP and recommend best practices to move forward. Additionally, we discuss areas to prioritize and proactively address for USP 797 compliance.
The following topic areas are explored in addition to others:
Assigning Beyond-use Dates
The use of Master Formulation and Compounding Records
Best practices for Air & Surface Sampling
Establishing a Designated Person
Review of Engineering Controls
Requirements for Personal Hygiene & Garbing